Drugs

Don’t Drop Off-Label Marketing Enforcement: Law Professors

Yale Law School professors Jeanie Kim and Amy Kapczynski urge FDA not to back down on its opposition to off-label marketing of drugs. Writing in JAMA Internal Medicine, the two say that the current approach to off-label marketing “has protected the public and helped provide physicians with rigorous evidence over many decades. Drug companies’ disputed First Amendment rights should not catalyze a major shift in the agency’s enforcement authority; any changes should be approached with an abundance of caution.”

The authors note that the agency’s approach has been jeopardized by recent Supreme Court decisions strengthening First Amendment protection for companies. “Although the legal issues — whether FDA’s restrictions on off-label marketing are unconstitutional — remains unresolved,” they write, “the agency has initiated a comprehensive review of its approach to off-label marketing.” An 11/9-10 public hearing will address the issue.

The article says that FDA has additional legal arguments on its side and should vigorously defend its existing regulatory regime by bringing cases against off-label promotion and fully litigating them. For example, it says, commercial speech is not an absolute right and can be regulated to ensure that the public has access to accurate and reliable information. “FDA’s restrictions on off-label marketing serve this end,” it says.

The professors caution that if the agency does not staunchly defend its authority to regulate off-label promotion, it may lose it incrementally. They suggest that the agency resolved one case by broadening the drug’s label without new evidence for the broader indication, and says that such a change ends up permitting marketing not only to doctors but also to the public.

They also note congressional pressure to ease the stance on off-label marketing. In May, two top Republican members of the House Energy and Commerce Committee wrote to HHS secretary Sylvia Burwell asking that FDA be urged to revise its rules and guidance to permit drug companies to promote off-label uses and raising the possibility of legislative amendment if FDA did not act on its own.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome